Efficacy and Safety of Left Atrial Appendage Closure With WATCHMAN in Japanese Nonvalvular Atrial Fibrillation Patients　― Final 2-Year Follow-up Outcome Data From the SALUTE Trial ―

Abstract

revious trials have demonstrated that more than 90% of thrombi from the heart originate in the left atrial appendage (LAA) in patients with atrial fibrillation (AF). 1 The WATCHMAN TM Left Atrial Appendage Closure (LAAC) device (Boston Scientific, St. Paul, MN, USA) is intended to permanently seal off the LAA and provides an alternative to long-term oral anticoagulation (OAC) therapy for stroke prevention.

2-Year Outcomes of Left Atrial Appendage Occlusion With WATCHMAN in Japanese Atrial Fibrillation Patients

“…7,8 In the SALUTE trial, the major bleeding rate was approximately 2.4% (2 events/84 patient-years, Figure 2). 6 The incidence of major bleeding in Asian patients was similar to that in North American/ European patients. Asian patients inherently have a higher bleeding risk than non-Asian patients, posing a clinical conundrum for AF patients on OAC, and may take advantage of LAAO more than non-Asian patients in terms of preventing major bleeding.…”

“…as reported in previous studies, which may be an advantage of LAAO with the WATCHMAN. 4,6 LAAO with the WATCHMAN has shown long-term benefit over warfarin therapy and will be an alternative to conventional OAC in NVAF patients. 4 However, there are still unresolved issues with this treatment.…”

JCS/JHRS 2021 guideline focused update on non‐pharmacotherapy of cardiac arrhythmias

“…However, sufficient clinical experience has since accumulated in both Japan and abroad, to understand the appropriate indications, safety, postoperative management, and long-term efficacy of this therapy. 19 Therefore, we describe the class recommendations for this novel technology in the present focused update.…”

JCS/JHRS 2021 Guideline Focused Update on Non-Pharmacotherapy of Cardiac Arrhythmias

“…164 During a 2-year follow-up, there were 3 ischemic events (7.1%) without any sequelae. 19 Successful LAAC, defined as a peri-device leak ≤5 mm, was achieved in all patients, but an asymptomatic device thrombus was detected in 2 patients (4.8%). 19 In a combined analysis of 2 RCTs and 2 large registries, the incidence of device thrombus was 3.7%, 165 similar to that of the SALUTE trial.…”

“…However, sufficient clinical experience has since accumulated in both Japan and abroad, to understand the appropriate indications, safety, postoperative management, and long-term efficacy of this therapy. 19 Therefore, we describe the class recom-mendations for this novel technology in the present focused update.…”